Employment Type: Full-Time
Responsible for performing the scientific activities in a product development environment. Responsible for performing analysis and pump compatibility studies. Prepare technical protocols, reports and perform quantitative analyses of protein and peptides in formulated drug products, raw materials (excipients). Assist in Product development. Other activities include assisting scientific presentations.
Independently determines task and steps involved for project/work assigned:
* Perform stability studies, method development, method validation and sample analysis support for product development activities.
* Performs analysis of finished products and raw material samples.
* Develops new methods and techniques.
* Executes development plan and project work.
* Validates analytical methods.
* Performs compatibility studies.
* Make laboratory formulations for pharmaceutical products.
* Prepares technical reports, protocols and data analysis.
* Plays an integral role in the strategy and tactical operations of the analytical department.
* Accomplish multiple projects/ sub-projects simultaneously including preparing scientific presentations and research articles.
* Develops, improves and validates analytical methods; thorough technical understanding of analytical methods and instruments is required.
* Performs analytical testing for qualitative and quantitative determinations of polymer degradation products, drug elution in support of product development, quality control and stability.
* Provides direct hands-on laboratory support and applies complete understanding of underlying Chemistry in work assigned and performed.
* Performs routine and non-routine analyses. Demonstrates flexibility with respect to completion of programs and projects.
* Generates datasheets for calculation of analytical parameters.
* Applies a broad range of analytical techniques in chromatography (e.g., HPLC and GC) and/or spectroscopic techniques, FTIR, UV-Vis), dissolution techniques and bioassay for routine and non-routine analyses in support of product development related activities
Maintains and strengthens a collaborative environment within the Drug Delivery Systems group and across cross-functional teams.
* Perform analytical testing in a cGMP - follows written procedures and documents variances to written procedures.
* Ensures all experiments comply with safe laboratory practices and standards
* Frequently application of regulatory standards to drugs and devices.
Outlines and implements solutions to laboratory problems and investigations.
* Independently investigates analytical problems, and find solutions.
* Provides preventative maintenance models on reducing lab errors.
* Performs routine laboratory duties that include general lab and glassware cleaning, sample and standards preparation, and housekeeping.
* Prepares reagents and solutions required for analyses.
* Performs steps that evolve from analytical projects.
* Performs additional lab and chemistry duties as assigned.
Basic Qualifications: 1) EDUCATION REQUIRED: (No equivalencies)
Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree in Science from four-year college or university (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A)).
1) YEARS OF EXPERIENCE: 0 years of experience required. 3) SPECIALIZED KNOWLEDGE REQUIRED (objective, relevant, and non-comparative)
* Experience applying numerous chemical analysis techniques to method development and materials or product characterization in an academic research or industry setting
* Experience with analytical techniques (examples include FTIR, UV-Vis, HPLC, GC,
spectroscopic techniques, Dissolution)
* Experience in analytical chemistry.
* Experience performing laboratory data interpretation including working with
mathematical concepts relevant to the laboratory setting.
* Degree in Biochemistry, Chemistry or Analytical Chemistry.
* Experience with HPLC, GC, IC, spectroscopic techniques, Dissolution.
* Experience in healthcare industry.
* Backgrounds in Karl Fisher, C/S/H/N/O testing and wet chemistry methods.
* Experience in insulin chemistry laboratory.
* Strong hands-on problem solving ability.
* Exceptional commitment to working in a collaborative and dynamic research field.
* Strong time management and prioritization skills are required for management of multiple projects.